Identity
- Trade Name
- VITROS FDA UDI
- Generic Name
- Theophylline therapeutic drug monitoring IVD, reagent FDA UDI
- Device Name
- VITROS Chemistry Products THEO Slides FDA UDI
- Model / Reference
- 1307164 FDA UDI
- Description
- VITROS Chemistry Products THEO Slides FDA UDI
Identifiers
- Catalog Number
- 1307164 FDA UDI
- Primary DI / UDI-DI
- 10758750008759 FDA UDI
- FDA Product Code
- KLS FDA UDI
- GMDN Term
- Theophylline therapeutic drug monitoring IVD, reagent FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.3880 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Theophylline therapeutic drug monitoring IVD, reagent
Vitros by Ortho-Clinical Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Theophylline therapeutic drug monitoring IVD, reagent.
- VITROS — Ortho-Clinical Diagnostics · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ortho-Clinical Diagnostics
Sources (1)
- FDA UDI 4b7dd321-a457-4646-aba3-7865914378c3 35 fields · synced May 30, 2026